RESEARCH ETHICS

[Link] Rao
 OBJECTIVES
• Discuss what is meant by and why there
should be ethical standards in research

• Identify ethical issues in research which would

amount to scientific misconduct

• Explain the role of an ethics review committee

• Construct a set of guidelines for members of

ethics review committees
 Research Ethics…..

• Involves the application of fundamental

ethical principles to planning, conducting
& publishing of research
 Guiding principles

–Autonomy and respect

–Beneficence
–Non-maleficence
–Justice ( free from exploitation)
–Scientific validity
–Honesty
 Student activity

Identify ethical issues in the

following scenarios
 Group 1
Two graduate students have made some
measurements on a new material. The data points
are as shown. To prove their hypothesis the
results should lie on the curve shown. The two
students considered omitting the two data points
which were off the theoretical curve.
• Unethical as it would amount to
falsification of data

• Should include outliers and give

probable reasons or find out
statistically acceptable ways of
trimming outliers
 Group 2

A group of medical students conducted a

research on the awareness of diabetic diet
in medical clinic participants. Their
research was recognized as the best
undergraduate research and later they
submitted the same research paper to two
different journals to see which journal
publishes it first.
• Unethical as it would result in "inadvertent
double-counting or inappropriate
weighting of the results of a single
study, which distorts the available
evidence
• it would give a false idea of the number of
publications in a given area
• wasting of resources on the review and
publication process

• Should submit to one journal and wait for

response prior to submitting to another
 Group 3

Students are required to prepare a research

proposal during their undergraduate program.
Nimal developed the idea for his project and
discussed with a friend. Several months later,
he found that his idea had been submitted as a
research proposal by his friend without his
knowledge.
• Unethical as failure to give credit to the
person whose idea it is (intellectual
property) amounts to plagiarism

• Should discuss and include as co-

author
 Group 4

Four friends decide to work together on a

research project during the vacation. One
of them went abroad during the vacation
and did not contribute to the research.
The friends include all 4 names in a
presentation made at a scientific
congress.
• Unethical as only those who
contributed intellectually should be
cited as authors

• Those who contribute in other ways

may be acknowledged
 Group 5

A group of undergraduate students

planned a research project on the
detection of fetal abnormalities in the
second trimester, by ultrasound
scanning. They collected data from the
scan room without informing the mothers
• Unethical as informed consent was
not taken

• Should have informed mothers of

their intent even though there is no
particular advantage/disadvantage to
the mother in doing so
 Group 6

A group of undergraduate students

collected data from a group of bank
officers, with their consent, regarding their
working hours and salary with regards to
the prevalence of high blood pressure.
Subsequently the researchers gave the
same data to another group who were in
need of same data variables.
• Unethical as violating principles of
consent and confidentiality

• Data can be used for a secondary

purpose which was not first considered
as long as
- informed consent for sharing has been
given
- identities anonymised
- due consideration to access restrictions
• Develop ethical guidelines for data
sharing?
Why should there be research ethics?

• To protect participants /patients /society

/resources /researcher?

• To ensure accuracy of scientific

knowledge

• To protect intellectual and property rights

• Must be of social value: improvement of
health/knowledge for the benefit of
society/science

high social value: use of stem cells to improve

quality of life for Huntington's disease patients

less social value: drug studies conducted to

obtain data that allows a new drug to compete in
the healthcare marketplace even though existing
effective and often cheaper therapeutics are
already available
To ensure accuracy of scientific knowledge
• Should be methodically rigorous -
Scientific validity
• Fair subject selection: with inclusion /
exclusion criteria & a valid number of
subjects in order to project results to the
population
• State research method clearly so that
another person can conduct advanced
study in future by using publication
Is it ethical to copy the methodology from a
published paper?
• Do not gloss research method
• Should not falsify/modify/omit data
• Use actual data for analysis/cannot
include someone else's data
• Report errors
• Be aware of conflict of interest
• Should not withhold and/or ‘vaguing up’
information
• Keep data and material for 5 years
• Data and material should be available to
others
• Do not present/publish paper from
incomplete research or from anticipated
outcomes
• Should not duplicate publications and
submissions
• Avoid piecemeal publication
• Should be reviewed Independently by
unaffiliated individuals
 To protect intellectual and property
rights

• Citation and authorship

inclusion-Writing and significant
scientific contribution
order- order of contribution
-actual researchers
-approval must be sought to
include a name
• Whenever somebody else’s work is
quoted reference should be made to
the original author (Piracy vs
plagiarism)

• Acknowledgement should include

the names of person who helped
Breach of ethics in research
would amount to scientific
misconduct
 Scientific misconduct
• Fraud : invention/fabrication of data

• Plagiarism : copying data, ideas, text

without acknowledgement of source

• Piracy : infringement of a copyright

• Submitting/Publishing the same paper to

different journals
 Scientific misconduct …
• Not informing a collaborator of your
intent to file a patent in order to make
sure that you are the sole inventor

• Including a colleague as an author on a

paper in return for a favor even though
the colleague did not make a serious
contribution to the paper
• Trimming outliers from a data set without
discussing your reasons in paper

• Using an inappropriate statistical

technique in order to enhance the
significance of your research

• Bypassing the peer review process and

announcing your results through a press
conference without giving peers
adequate information to review your work
• Conducting a review of the literature that
fails to acknowledge contributions of
others

• Stretching the truth on a grant application

in order to convince reviewers that your
project will make a significant contribution
to the field

• Giving the same research project to two

graduate students in order to see who can
do it the fastest
• Overworking, neglecting, or exploiting
research students

• Making derogatory comments and

personal attacks in your review of
author's submission

• Making significant deviations from the

research protocol approved by the
Review Board without informing the
committee
• Not reporting an adverse event in a
human research experiment

• Wasting animals in research

• Exposing students and staff to biological

risks

• Rejecting a manuscript for publication

without even reading it
• Sabotaging someone's work

• Rigging an experiment so you know how

it will turn out

• Deliberately overestimating the clinical

significance of a new drug in order to
obtain economic benefits
 Ethical review committee
(Institutional Review Boards)
Convened to
– maintain ethical standards of practice in
research
– ensure protection of subjects/research
workers from harm or exploitation
– to provide reassurance to the public
– protect researchers from unjustified
criticism
 Procedure for ethical clearance

• Fill ethical clearance form and attach

proposal, questionnaires, informed
consent forms, information leaflets
etc., and submit
• When ethical clearance is granted,
data collection can commence
according to the approved
methodology
• A group of undergraduate students
planned a research on family planning
practices of Sri Lankan females. As they
were close to the deadline for presenting
their results, they started collecting
information form participants before
formal approval by the ethics review
committee
• What should members of ethics
review committees consider in
evaluating a proposal for ethical
clearance?
• Elements of a review
An ethics committee will assess whether:

• the research is justified, i.e. is the research likely to

add to the existing knowledge base;
• it is of sufficient standard - including whether the
researchers are qualified to carry out the roles
proposed;
• the risk it poses to participants is outweighed by the
potential benefits of the research?;
• the research appears to comply with all statutory and
other guidance;
• data management and handling appears to comply
with the relevant legislation;
• financial arrangements appear sound.
THANK YOU